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Impact of Insulin Resistance on Therapeutic Response for Oral Treatment of Chronic Hepatitis C Virus Infection

Primary Purpose

Hepatitis C

Status
Unknown status
Phase
Locations
Egypt
Study Type
Observational
Intervention
fasting serum insulin
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Hepatitis C

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The study is intended to include patients with chronic HCV infection.

Exclusion Criteria:

  • Presence of large risky esophageal varices (except after successful prophylactic banding).
  • Uncontrolled ascites.
  • Patients with hepatocellular carcinoma except after successful curative intervention (3 months after resection or successful loco-regional therapy).
  • Child score of 8 or less.
  • Total serum bilirubin of 5 mg/dL or less.
  • Platelet count of 30000/mm3 or more.
  • Hemoglobin level of 10 g/DL or more.

Sites / Locations

  • Assiut UniversityRecruiting

Outcomes

Primary Outcome Measures

fasting serum insulin
which is estimated fasting serum insulin in micro international unit per millileter

Secondary Outcome Measures

Full Information

First Posted
July 7, 2017
Last Updated
July 7, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03212833
Brief Title
Impact of Insulin Resistance on Therapeutic Response for Oral Treatment of Chronic Hepatitis C Virus Infection
Official Title
Impact of Insulin Resistance on Therapeutic Response for Oral Treatment of Chronic Hepatitis C Virus Infection
Study Type
Observational

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Globally, approximately 170 million people are infected with hepatitis C virus (HCV); 350,000 deaths each year are caused by HCV infection (Perz,et al, 2006).The Egyptian Demographic Health Survey (EDHS), across sectional survey including hepatitis C virus (HCV)biomarkers, was conducted in 2008 on a large nationally representative sample (El-Zanaty F, et al 2009). It estimated HCV prevalence among the 15-59 years age group to be 14.7% (El-Zanaty F, et al 2009).Accordingly, Egypt has the highest HCV prevalence in the world (Lavanchy D, 2011), ( Shepard CW,et al 2005)..Interferon (INF)-free regimens of combined directly acting antivirals (DAAs) have shown improved efficacy and tolerability compared with interferon (IFN)-containing regimens, and they have become the standard of care for treatment of HCV genotype-1 (HCV-1)(Afdhal, et al, 2014).Insulin resistance is a state in which a given concentration of insulin produces a less-than-expected biological effect. The prevalence of type 2 diabetes mellitus in hepatitis C in cirrhotic patients is 27.3% which is higher than among non-cirrhotic hepatitis C patients (17.5%)(Romero-Gómez, 2006). HCV promotes insulin resistance and insulin resistance induces interferon resistance, steatosis and fibrosis progression in a genotype-dependent manner.In HCV-1, insulin resistance decreases sustained response rate, and increase the risk for the development of steatosis and fibrosis progression, However, the impact of insulin resistance in other genotypes seems not achieve enough importance to impair sustained response, probably due to the high sensitivity to peginterferon. The treatment of insulin resistance, decreasing hyperinsulinemia, could improve sustained response rate in patients with chronic HCV-1 infection when treated with peginterferon plus ribavirin(Romero-Gómez,2006). Objectives: we aim to determine the prevalence of insulin resistance among the patients with chronic hepatitis C virus( HCV) infection and to explore the association between insulin resistance and therapeutic response by comparing the insulin resistance among responders and non-responders to oral treatment of chronic hepatitis C virus infection Patients and methods: The study is intended to include patients of chronic hepatitis C virus infection receiving oral treatment for one year period. All patients will have clinical evaluation, ultrasonographic examination, and laboratory investigations which include complete blood count, liver function tests, estimation of fasting serum glucose, fasting serum insulin, and determination of insulin resistance index.The patients will be selected according the selection criteria determined by the National Committee for Control of Viral Hepatitis (NCCVH).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
fasting serum insulin
Intervention Description
fasting serum insulin in chronic hepatitis C patients
Primary Outcome Measure Information:
Title
fasting serum insulin
Description
which is estimated fasting serum insulin in micro international unit per millileter
Time Frame
10 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study is intended to include patients with chronic HCV infection. Exclusion Criteria: Presence of large risky esophageal varices (except after successful prophylactic banding). Uncontrolled ascites. Patients with hepatocellular carcinoma except after successful curative intervention (3 months after resection or successful loco-regional therapy). Child score of 8 or less. Total serum bilirubin of 5 mg/dL or less. Platelet count of 30000/mm3 or more. Hemoglobin level of 10 g/DL or more.
Study Population Description
patients with chronic HCV infection
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rasha H Sayed, master
Phone
00201093241729
Email
rashrusha@yahoo.com
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasha H Sayed, master
Phone
00201093241729
Email
rashrusha@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Impact of Insulin Resistance on Therapeutic Response for Oral Treatment of Chronic Hepatitis C Virus Infection

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